What is a Deviation? A deviation should not be viewed as your “worst nightmare”. Instead, a deviation should be seen as a way to root out inefficiencies in your biopharmaceutical manufacturing process. A deviation is a departure from the norm…
What’s the Word? In 2023, the FDA issued a total of five hundred and ten (510) 483 Warning Letters in the Drug Category. In the Biologics category, forty-five (45) 483 Warning Letters were issued. FDA 483 Warning Letters are issued…
A look back at the last decade in the numbers of FDA 483 Warning Letters issued show a significant dip during the height of the pandemic. FDA 483 Warning Letters are issued following a site visit when conditions found do…
Many times, when a complex piece of process equipment is part of a deviation, it can be difficult to pinpoint the root cause. This is partly because the root cause now involves reaching out beyond your core group and working…
When things get complicated Question: How do you get to the root cause when things start getting technically complex? Answer: Keep asking questions. Especially when things start getting outside of your wheelhouse, that's when you start asking even more questions. …
Reflection As we navigate the dynamic landscape of the pharmaceutical industry in 2023, the winds of change are ushering in transformative trends that are shaping the future of our field in 2024 and beyond. From our vantage point, the pharmaceutical…
What does CIP mean? CIP stands for Cleaning in Place. In the biopharmaceutical manufacturing industry, most vessels such as bioreactors are cleaned without being dismantled. Special cleaning solutions are used to remove any residue left after the bioreactor has been…
What is an (M)SDS? (M)SDS stands for (Material) Safety Data Sheet. The "M" has been dropped from modern designations. An SDS describes all of the properties, hazards and safety precautions associated with a chemical. How to search for an (M)SDS…
What does “normal” look like when it comes to process equipment? Troubleshooting process equipment is the core role of Process Engineers at a biopharmaceutical facility. Before you can identify a problem with the equipment, you need to know what “normal”…
The only constant in life is change.” This famous quote from Greek philosopher, Heraclitus, rings true today. Every day ends with a sunset. Depending on where you live, it can be breathtaking. The sun eventually hides behind the mountains for…